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The NADage study

This study is seeking older participants who feel their health is starting to decline, or who find that aging is beginning to weigh on their everyday life.

The purpose of the study is to explore whether a dietary supplement called vitamin B3, in the form of nicotinamide riboside (NR), can improve physical and cognitive function in older adults.

Aging is linked to a loss of physical and cognitive function, which affects quality of life for individuals, their relatives, and society. Furthermore, the prevalence of dementia increases among individuals with age-related functional decline.

The results of this study will provide a better understanding of how NR affects the body’s and brain’s function and metabolism. The project has the potential to offer new insights into whether, and if so how, NR may reduce age-related functional decline. If NR proves to be effective, it could provide a new, non-invasive treatment method that can improve the quality of life for a large number of older adults.

In the study, participants will be randomized to receive a high dose of vitamin B3 in the form of NR, or placebo (sugar pill).

Vitamin B3/NR is classified as a dietary supplement by the Norwegian Medicines Agency. The substance has no known toxic or harmful effects, and no significant side effects are expected. The medication is taken orally, in pill form.

Recruiting

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Haukeland hospital
Norway
Katarina Lundervold

Katarina Lundervold

Principal Investigator, MD, PHD Student

MD Katarina Lundervold is a resident in neurology at the Haukeland University Hospital and currently a PhD candidate at Neuro-SysMed. Her PhD research focuses on the brain-gut axis to improve our understanding of preclinical and clinical gastrointestinal biomarkers to make advancement towards developing a neuroprotective therapy in Parkinson disease.

Is this study right for you?

These question should help you determine if this study might be right for you, but is not an absolute answer. If you recognize yourself in at least 3 of these points, you may be a candidate for participation:

  • The participant must understand the nature of the study and be able to provide written informed consent.
  • Men or women aged ≥ 75 years at study start.
  • Assessment of age-related physical frailty.
  • Assessment of cognitive functional levels.

All participants in the study will receive either the study medication in the form of Nicotinamide Riboside (NR) at a dose of 2000 mg daily or a placebo (tablet with no active ingredient, just starch) for 52 weeks. The study medication is in tablet form and should be taken daily. Neither you nor your study doctor will know whether you are receiving NR or placebo until the study is completed. After the study ends, we will compare the results between those who received NR and those who received a placebo. This will allow us to distinguish between a real biological effect of vitamin B3 and a perceived effect, known as the placebo effect.

Before starting the study, one of the study doctors will invite you to a physical visit called a screening assessment. During this visit, we will ask about your medical history, medications you use, and conduct a thorough physical examination. At this screening visit, we will explain what the study involves and determine if you meet the criteria to participate. If you meet the criteria, is motivated to participate, and consent to participation, you will be invited to the first study visit.

Study Location:
The study is both led and conducted by Neuro-SysMed, a neurological research group at Haukeland University Hospital. Throughout the study, you will attend follow-up visits at the hospital in weeks 1, 26, and 52, with consultations lasting between 60 and 180 minutes.

Tests and Examinations:
Before the first visit, you will wear a portable watch for one week. This watch will monitor movements, potential falls, and general activity levels. You will also receive a sensor to place near your bed to record sleep patterns at home. You will be referred for a hearing test and radiological examinations. MRI imaging of the brain and FDG-PET scans will be conducted before or in connection with the first and last study visit. FDG-PET is an examination using radioactive tracers to visualize brain structures and activity; this examination is only for the first participants in the study.

Study visits will include medical examinations, various tests, cognitive assessments, and questionnaires on symptoms and quality of life. We will also take blood samples to ensure the study medication’s safety and research blood samples to investigate its effects on various blood markers.

In weeks 12 and 40, we will call you to check on your status and record any side effects. During these phone follow-ups, you will also need to provide blood samples.

 

Contact this study today!

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Have questions about our clinical studies or need more information on how to participate. Our team is here to provide you with all the details you need. Don’t hesitate to reach out to us today!